Intervention for Chronic Insufficient Sleep in Young Adult Cancer Patients and Survivors
2 other identifiers
interventional
74
0 countries
N/A
Brief Summary
Young adult cancer survivors (YACS) commonly experience chronic insomnia due to many factors such as cancer related symptoms, effects of anti-cancer therapies, co-morbid mood disorders, and/or other psychosocial and economic stressors. Cognitive behavioral therapy for insomnia (CBT-I) is the gold standard for insomnia management but remains challenging to deliver to patients due to limited numbers of trained therapists, inconvenient scheduling availability, or prohibitive therapy costs. To address this critical gap in young adult cancer survivorship, the investigators propose to develop and test efficacy of the More Sleep Hours Electronic Education Program (More SHEEP), a novel system of smart speaker, smart lighting, and specialized Wi-Fi router that delivers AI-driven CBT-I to patients at home.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started Jan 2026
Typical duration for not_applicable cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2028
January 6, 2026
December 1, 2025
2.4 years
September 8, 2025
January 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insomnia Severity Index
The Insomnia Severity Index (ISI) is a validated 7-item self-reported questionnaire assessing the severity of insomnia symptoms and related daytime impairment over the past two weeks. Items are scored on a 0-4 scale, producing a total score from 0 to 28, with higher scores indicating greater insomnia severity.
Baseline (Day 0) and Post Intervention (6 Weeks)
Secondary Outcomes (5)
Functional Assessment of Cancer Therapy - General
Baseline (Day 0) and Post Intervention (6 Weeks)
Functional Assessment of Cancer Therapy - Cognitive Function
Baseline (Day 0) and Post Intervention (6 Weeks)
Satisfaction with Assigned Study Intervention (Client Satisfaction Questionnaire)
Post Intervention (6 Weeks)
Recommendation of Assigned Intervention to Family/Friends
Post Intervention (6 Weeks)
System Usability Scale
Post Intervention (6 Weeks)
Study Arms (2)
Voice-activated virtual assistant-delivered cognitive behavioral therapy for insomnia
EXPERIMENTALMore Sleep Hours Electronic Education Program (More SHEEP) is a home-based, technology-enabled intervention that delivers cognitive behavioral therapy for insomnia (CBT-I) to young adult cancer survivors. The intervention uses a screen-free, voice-activated smart speaker integrated with adaptive smart lighting and internet use monitoring to provide CBT-I components including sleep education, sleep scheduling, behavioral recommendations, and daily sleep diary collection over a 6-week period.
Voice-activated virtual assistant-delivered sleep management skills (not CBT-I)
ACTIVE COMPARATORThe active comparator arm will include the same hardware as the More SHEEP system, a screen-free, voice-activated smart speaker integrated with adaptive smart lighting and internet use monitoring, but will not deliver CBT-I, it will only include skills education to improve sleep.
Interventions
Cognitive Behavioral Therapy for Insomnia (CBT-I) is a structured, evidence-based treatment that helps people change thoughts and behaviors that interfere with sleep, using techniques like stimulus control, sleep restriction, cognitive restructuring, and relaxation training.
Daily education about building better sleep habits, sleep hygiene, diet and exercise related to sleep
Eligibility Criteria
You may qualify if:
- Age 18-42 at time of enrollment
- history of cancer diagnosis (any type) diagnosed at/after age 15, received all treatment before age 40
- at least 6 months from date of cancer diagnosis
- history of chronic sleep disorder with Insomnia Severity Index \>/= 8
You may not qualify if:
- Refusal to try the study intervention
- diagnosed untreated obstructive sleep apnea syndrome, or restless leg syndrome
- narcolepsy, schizophrenia, bi-polar disorder, and/or poorly controlled psychiatric diagnoses
- disease-related prognosis of less than 6 months or currently enrolled in hospice care
- planned travel out of the continental United States during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medstar Health Research Institutelead
- National Cancer Institute (NCI)collaborator
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hunter Groninger, MD
Medstar Health Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2025
First Posted
January 6, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
May 31, 2028
Last Updated
January 6, 2026
Record last verified: 2025-12